Top Quality Manufacturing

Basic Information

• Brand Name: Top Quality Manufacturing
• Primary DI: TQ26180121011
• Version / Model: 18012101
• Company Name: TOP QUALITY MANUFACTURING, INC.
• Labeler DUNS: 113630649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-09
• Public Version: 1
• Public Version Date: 2024-12-17
• Public Version Status: New
• Public Device Record Key: 2b850f33-7894-49c2-8b51-a47d069de981

Device Description

TQMPL Impression Gun - High Performance HP - 50 ml - 1:1 Ratio

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60885	Dental material cartridge-plunging applicator, two-component, manual	A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	TQ26180121011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]